UMIN-CTR Clinical Trial

Basic information
Public title	Predictors of cognitive behavioral therapy for chronic pain
Acronym	Predictors of cognitive behavioral therapy for chronic pain
Scientific Title	Predictors of cognitive behavioral therapy for chronic pain
Scientific Title:Acronym	Predictors of cognitive behavioral therapy for chronic pain
Region	Japan

Condition
Condition	chronic pain
Classification by specialty	Psychiatry Anesthesiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examine the predictors of pain symptoms, pain disability, or quality of life during cognitive behavioral therapy for chronic pain
Basic objectives2	Others
Basic objectives -Others	I. To examine the baseline predictors of pain symptoms, pain disability, or quality of life during cognitive behavioral therapy for chronic pain II. To examine the relationship between the changes in clinical factors and the chages in pain symptoms, pain disability, or quality of life during cognitive behavioral therapy for chronic pain
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Numerical Rating Scale (NRS)
Key secondary outcomes	Short-Form McGill Pain Quetionnaire2(SF-MPQ-2), Pain Catastrophizing Scale(PCS),Pain Self-Efficacy Questionnaire(PSEQ),Hospital Anxiety and Depression Scale(HADS),Somatic Symptom Scale-8(SSS-8),Behavioral Approach System / Behavioral Inhibition System Scales (BAS/BIS Scales), Effortful Control Scale for Ad1ults(ECS),Pain Disability Assessment Scale(PDAS),EuroQol-5 Dimensions-5 Level (EQ-5D-5L)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	cognitive behavioral therapy, once a week,two hours, twelve sessions
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)outpatients of pain center in Nogoya City University Hospital 2)chronic pain without organic disease 3)more than three months durartion
Key exclusion criteria	developmental disorder, current psychosis, bipolar disorder and substance-use disorder.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Sei Middle name Last name Ogawa
Organization	Nagoya City University
Division name	Graduate School of Humanities and Social Sciences
Zip code	467-8501
Address	Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL	052-872-5186
Email	seiogawa1964@nifty.com

Public contact
Name of contact person	1st name Sei Middle name Last name Ogawa
Organization	Nagoya City University
Division name	Graduate School of Humanities and Social Sciences
Zip code	467-8501
Address	Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL	052-872-5186
Homepage URL
Email	seiogawa1964@nifty.com

Sponsor
Institute	Graduate School of Humanities and Social Sciences Nagoya City University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science, and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya City University
Address	Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel	052-851-5511
Email	clinical_research@med.nagoya-cu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 22 Day
Date of IRB	2017 Year 10 Month 10 Day
Anticipated trial start date	2017 Year 10 Month 11 Day
Last follow-up date	2020 Year 10 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 23 Day
Last modified on	2019 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031961